Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015192261

FEI Number

3015192261

Entity Name

Resonetics, LLC

City/State/Country

Or Akiva Central, IL

Establishment Address

9 Hahadas Street, Or Akiva Central 3060000, IL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Resonetics, LLC (Owner Number: 10078190)

Owner / Operator Contact Address

26 Whipple Street, Nashua, NH 03060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Electrosurgical, cutting & coagulation & accessories GEI - Electrosurgical, cutting & coagulation & accessories Electrosurgical, cutting & coagulation & accessories InModeRF Applicator Electrosurgical, cutting & coagulation & accessories InModeRF Applicator Tape, Measuring, Rulers and Calipers Electrosurgical, cutting & coagulation & accessories EnPlace Extravascular support for an arteriovenous fistula for vascular access Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilatation Balloon System with Integrated Embolic Protection InModeRF Applicator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-22
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2024-04-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-22
PBQ	Fixation, Non-Absorbable Or Absorbable, For Pelvic Use	Obstetrics/Gynecology	Class 2	884.4530	2024-11-08
QVQ	Extravascular Support For An Arteriovenous Fistula For Vascular Access	Cardiovascular	Class 2	870.4600	2024-04-04
NIM	Stent, Carotid	Unknown	Class 3	N/A	2024-11-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-22

Official Correspondent

No official correspondent registered.

US Agent Details

Andrea Nicolaisen Business: Resonetics Email: anicolaisen@resonetics.com Phone: (978) 3763504

Related Public Records

Same Entity

Resonetics, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011752740	AGILE MV	Montreal Quebec, CA
3004579081	MEMRY CORPORATION	Bethel, CT, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015192261. Last updated year: 2026. Please use registration number 3015192261 when referencing this establishment in official correspondence.